Digital Cognitive Behavioral Therapy for Depressive Disorders

Not Applicable

Recruiting

• Conditions: Depression; Anxiety
• Interventions: Behavioral: Digital Cognitive Behavioral Therapy; Behavioral: Health Education; Drug: TAU

• Registration Number: NCT06423443
• Lead Sponsor: Adai Technology (Beijing) Co., Ltd.

Brief Summary

This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-20
• Status Verified: 2024-05
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-21
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient.
2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization.
3. Age ≥ 18 and ≤ 65 years, regardless of gender.
4. Understands the trial and signs the informed consent form.

Exclusion Criteria

1. Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions.
2. History of substance and/or alcohol abuse within the past year.
3. Significant risk of suicide (MADRS item 10 score = 4).
4. Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment.
5. Inability to use a smartphone.
6. Deemed unsuitable for participation by the researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Cognitive Behavioral Therapy	Digital Cognitive Behavioral Therapy	-
Digital Cognitive Behavioral Therapy	TAU	-
Health Education	Health Education	-
Health Education	TAU	-

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months	Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms.

Secondary Outcome Measures

Name	Time	Method
GAD-7 (Generalized Anxiety Disorder-7)	baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months	GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms.
Pittsburgh Sleep Quality Index (PSQI)	baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months	Score Range: 0 (best outcome) to 21 (worst outcome) Higher scores indicate poorer sleep quality.
Snaith-Hamilton Pleasure Scale (SHAPS)	baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months	Score Range: 14 (best outcome) to 56 (worst outcome) Higher scores indicate greater levels of anhedonia (reduced ability to experience pleasure).
PHQ-9 (Patient Health Questionnaire-9)	baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months	PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms.
Rumination Response Scale (RRS)	baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months	Score Range: 22 (best outcome) to 88 (worst outcome) Higher scores indicate higher levels of rumination.

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuang, China